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Medical information request

 

EXCHANGE

Interim analysis results1

Bar-Or A, et al. Safety and tolerability of conversion to siponimod in patients with relapsing multiple sclerosis: interim results of the EXCHANGE study. Poster presentation at ACTRIMS-ECTRIMS. 2020;P0233.

  • EXCHANGE evaluated overall safety and tolerability profile in patients with advancing RMS or a history of RMS** who convert from injectable and oral DMTs to dose-titrated siponimod without washout

  • Prospective, multicenter, open-label, single-arm trial

  • 113 patients included in interim analysis from 42 centers in the USA; 1 patient in the virtual arm

  • Patients with ≥1 AE (34.8%)

  • SAEs and AEs leading to drug discontinuation was low

    ‒ Five patients had ≥1 SAE^, six patients had ≥1 AE#

  • No notable reductions from baseline in mean heart rate at 6-hour post Day-1 dose

update exchange

Conversion from oral/injectable DMTs to siponimod without washout had an acceptable safety and tolerability profile, with no unexpected findings

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(New) COVID-19 vaccination EXCHANGE sub-study

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**Siponimod is approved in the US to treat relapsing forms of MS (CIS, RRMS and active SPMS) in adults2
^Multiple SAEs can occur in 1 patient; #multiple AEs leading to drug discontinuation can occur in 1 patient
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Abbreviations
AEs, adverse events; CI, confidence interval; DMTs, disease-modifying therapies; RMS, relapsing multiple sclerosis; SAEs, serious adverse events
Reference
1. Bar-Or A, et al. Poster presentation at ACTRIMS-ECTRIMS. 2020;P0233.
2. MAYZENT USPI: https://www.novartis.us/sites/www.novartis.us/files/mayzent.pdf
* Indication varies in different countries. Current website is a global information resource. Local Prescribing Information/ Summary of Product Characteristics approved by individual country’s regulatory authority is the primary source of information for the indication of siponimod in the individual country.

The Pregnancy outcome Intensive Monitoring (PRIM) program is based on enhanced pharmacovigilance of the Novartis spontaneous reporting system. PRIM is an adverse event outcomes intensive monitoring program to collect information (targeted follow-up checklists) about pregnancy in patients exposed to siponimod immediately before or during pregnancy and infant outcomes 12 months after delivery.